Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04480216 |
| Other study ID # |
P2019/643 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 19, 2020 |
| Est. completion date |
September 15, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Erasme University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A novel magnetic device, called MAgnetic Gastrointestinal Universal Septotome (MAGUS) was
designed to improve the Treatment of diverticulum of the esophagus, Pseudo-diverticulum of
the upper GI tract, Candy cane syndrome This study aims to evaluating the safety of the
feasability of this new device.
Description:
In this study, the investigators aim at treating different pathological conditions, resulting
in the appearance of a septum separating a healthy pathway and a pathological pouch. Food
then stagnate in this pouch and results in different symptoms including dysphagia, pain
and/or regurgitation or postprandial dysrhythmia.
Esophageal diverticula consists in the apparition of a pouch (diverticulum) alongside the
esophagus. Some post-surgical conditions can result in the appearance of pseudo-diverticulum
or afferent limb that transforms into a large pouch. One example is the candy cane syndrome,
being an afferent loop syndrome post gastrectomy or post Roux-en-Y Gastric Bypass, were the
afferent limb becomes a structure similar to a large diverticulum.
All those pathological conditions could be solved by the marsupialization of those
(pseudo-)diverticulum. For several years, Zenker's diverticula (pharyngo-esophageal
diverticulum) have been treated endoscopically using this technique, providing good clinical
results. However, it is difficult to go further than the pharynx with this technique, since
it needs specific semi-rigid tools and a stable cutting position. Hence, for further septa of
the GI tract, the classic treatment is thoracoscopy and thoracotomy or laparoscopy and
laparotomy, depending on the site. Those highly invasive procedures have a significant
mortality and morbidity rate respectively of more than 5% and 20% and are liked to different
complications including abdominal pain, port site wound infections, intraabdominal collection
or anastomosis ulcer.
The MAGUS device consists of a flexible catheter preloaded with a magnetic device, made of
two magnets linked by a wire. Each magnet is attached to the catheter and can be dropped
separately from this catheter. The magnetic device aims to create an anastomosis by means of
compression, using magnetic force and a retractable wire pulling system. For a given septum,
the magnets are placed on either sides of the bottom of it. The retractable wire goes then
from one another, passing on top of the septum. Both creates compression necrosis. This
process induces eventually a cutting of the septum.
Once the cutting is performed, the magnets migrate and are expelled through natural ways.
The MAGUS device is an endoscopic procedure. Above standard of care monitoring, safety
assessment of the procedure and device performance decreases the risk and unforeseen events.
